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1.
Sleep Science ; 15:84, 2022.
Article in English | EMBASE | ID: covidwho-1935295

ABSTRACT

Introduction: Sleep quality is influenced by several aspects, including factors related to the environment as well as psychological causes. In this context, the pandemic caused by the new SARS-Cov2 (severe acute respiratory syndrome coronavirus 2) had a large influence on the population's mental health, increasing levels of anxiety and stress, consequently reflected on the sleep quality. This is so also true for medical students;as a result of the scenario generated by the pandemic, in-person classes were replaced by distance education, which, added to the chaotic situation of fear, anxiety, frustration and social isolation, is interfering negatively in students' lives, and in their sleep. Objective: To analyze the sleep quality of medical students at a medical school in the interior of São Paulo state during the covid-19 pandemic. Methods: This is a crosssectional study that invited 544 students from De six years of the course, from a medical school in the interior of the state of São Paulo, to answer the Pittsburgh Sleep Quality Index (PSQI) and a questionnaire on aspects that may influence sleep. The REDCap platform was used to send, via email, the link to the questionnaires, which were available from September 28th to October 5th, 2020. Results: Of the 544 students invited, 375 answered the questionnaires. The mean score of PSQI was 8.63 (SD=3.16), with 82.4% (309 out of 375) of students having a poor sleep quality (PSQI>5). We observed an association between the quality of sleep given by the PSQI and the student's perception of anxiety (P<0.001), stress (P<0.001) and adaptation to distance education (P<0.001). The results for the seven components of the PSQI were analyzed for three study groups (1-2-year student, 3-4-year student and 5-6-year student) and associations were observed between the three studied groups and sleep duration, with students in the last two years sleeping less (<5/5-6h) than the remaining students, and with daytime dysfunction, with students in the first two years showing the highest percentage (75.5%). Conclusion: Sleep quality is poor in medical students, being associated with student's perception of anxiety, stress and difficulties in adapting to distance education. Active interventions should be implemented to improve sleep hygiene in medical students.

2.
Portuguese Journal of Pediatrics ; 53(2):473-483, 2022.
Article in English | Scopus | ID: covidwho-1893612

ABSTRACT

Introduction: Being a recent disease, there are still unknown facts about coronavirus disease 2019, especially in children. Therefore, reports from centers worldwide are important to better understand this condition. This study aimed to describe all severe acute respiratory syndrome coronavirus 2 positive cases admitted to a Portuguese tertiary pediatric hospital. Methods: All patients with severe acute respiratory syndrome coronavirus 2 infection confirmed by polymerase chain reaction test until January 31st, 2021, were included in this study. A descriptive analysis was conducted on demographic, epidemiological, clinical, and laboratorial characteristics, as well as patient management. Results: In total, 331 (3.8% of the total tested) patients were included in this study, 51.1% of whom were male, and the median age was 6 years (range 7 days-17 years), being the 1-5 years age group the more prevalent. Family / cohabitant contact was the main form of exposure to disease. Symptoms included fever (50.2%), cough (45%) and gastrointestinal symptoms (38.7%) (diarrhea in 13%). There were 10 patients with anosmia and eight with ageusia (all older than 5 years) and 14.8% of the children were asymptomatic. Excluding asymptomatic patients, hospitalization occurred in 17 (6.0%) cases, four of whom were adolescents (three obese, one with progressive cancer) and needed oxygen supplementation, and one patient was admitted to the intensive care unit. Discussion: In our center, pediatric infection rate was low, frequently with a mild clinical presentation and after a contact with an infected cohabitant / family member. Asymptomatic patients corresponded to 14.8% of the cases. Of the four patients with more severe disease, all were adolescents and three were obese. The outcome was overall good. © Author(s) (or their employer(s)) and Portuguese Journal of Pediatrics 2022. R.

3.
International Journal of Economics and Business Research ; 23(4):500-526, 2022.
Article in English | Scopus | ID: covidwho-1892352

ABSTRACT

Despite representing a recent world trend, wedding tourism felt a growth of 75% the past few years, which shows this market, specifically, the destination weddings niche, is proving to have an optimistic development and becoming a relevant topic in events tourism. The research objective analyses how the destination weddings have contributed for the development of events tourism in Portugal by examining what tactics are being utilised towards an international positioning. A quantitative method was used to achieve the objectives, being that two distinct surveys were elaborated, to foreign couples and another to vendors that take part in the industry. The data triangulation method was adopted with the goal of obtaining robust results by gathering a broader source of data. The results show that the destination weddings market contributes positively to the expansion of the events tourism in Portugal. Couples tend to choose Portugal for their climate, impressive sites and sense of intimacy, but the country needs to improve the transaction payments and present a wider range of advertisement. Regarding Covid-19, it had a negative influence mainly because most foreign couples decided to postpone or cancel the wedding. Copyright © 2022 Inderscience Enterprises Ltd.

4.
International Journal of Services, Economics and Management ; 13(2):152-181, 2022.
Article in English | Scopus | ID: covidwho-1875146

ABSTRACT

The pandemic has been a serious concern since its arrival in early 2020 around the globe. The aim of this research is to study the decay of the food and beverage industry, facing the pandemic of Covid-19. Throughout this research we have studied the classification of our sample, the fears and discomforts of our respondents regarding the new reality faced and the routine alteration of inquiries and by extension the impacted in the industry. In order to respond to these questions, we have based our investigation in the conception of a survey we have distributed and analysed a predictive model and clustering analysis. The findings drawn in this study were meaningful and lead us to the confirmation of the biggest fears and discomfort reasons when attending restaurants in a pandemic context but also the causes that make individuals reconsider their attendance in restaurant establishments. Copyright © 2022 Inderscience Enterprises Ltd.

5.
60th IEEE Conference on Decision and Control (CDC) ; : 3544-3550, 2021.
Article in English | Web of Science | ID: covidwho-1868528

ABSTRACT

We address the model identification and the computation of optimal vaccination policies for the coronavirus disease 2019 (COVID-19). We consider a stochastic Susceptible- Infected-Removed (SIR) model that captures the effect of multiple vaccine treatments, each requiring a different number of doses and providing different levels of protection against the disease. We show that the inclusion of vaccination data enables the estimation of the state of the model and key model parameters that are otherwise not identifiable. This estimates can, in turn, be used to design strategic approaches to vaccination that aim at minimizing the number of deaths and the economic cost of the disease. We illustrate these results with numerical examples.

7.
Advances in Laboratory Medicine ; 2(3):390-398, 2021.
Article in English | Scopus | ID: covidwho-1846966

ABSTRACT

Objectives: The strain the SARS-COV-2 pandemic is putting on hospitals requires that predictive values are identified for a rapid triage and management of patients at a higher risk of developing severe COVID-19. We developed and validated a prognostic model of COVID-19 severity. Methods: A descriptive, comparative study of patients with positive vs. negative PCR-RT for SARS-COV-2 and of patients who developed moderate vs. severe COVID-19 was conducted. The model was built based on analytical and demographic data and comorbidities of patients seen in an Emergency Department with symptoms consistent with COVID-19. A logistic regression model was designed from data of the COVID-19-positive cohort. Results: The sample was composed of 410 COVID-positive patients (303 with moderate disease and 107 with severe disease) and 81 COVID-negative patients. The predictive variables identified included lactate dehydrogenase, C-reactive protein, total proteins, urea, and platelets. Internal calibration showed an area under the ROC curve (AUC) of 0.88 (CI 95%: 0.85-0.92), with a rate of correct classifications of 85.2% for a cut-off value of 0.5. External validation (100 patients) yielded an AUC of 0.79 (95% CI: 0.71-0.89), with a rate of correct classifications of 73%. Conclusions: The predictive model identifies patients at a higher risk of developing severe COVID-19 at Emergency Department, with a first blood test and common parameters used in a clinical laboratory. This model may be a valuable tool for clinical planning and decision-making. © 2021 Yolanda Villena-Ortiz et al., published by De Gruyter, Berlin/Boston.

8.
Embase; 2021.
Preprint in English | EMBASE | ID: ppcovidwho-336175

ABSTRACT

Background: There is a need for better prediction of disease severity in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Soluble angiotensin-converting enzyme 2 (sACE2) arises from shedding of membrane ACE2 (mACE2) that is known to be a receptor for the spike protein of SARS-CoV-2;however, its value as a biomarker for disease severity is unknown. This study evaluated the predictive value of sACE2 in the context of other known biomarkers of inflammation and tissue damage (C-reactive protein [CRP], growth/differentiation factor-15 [GDF-15], interleukin-6 [IL-6], and soluble fms-like tyrosine kinase-1 [sFlt-1]) in patients with and without SARS-CoV-2 with different clinical outcomes. Methods: For univariate analyses, median differences between biomarker levels were calculated for the following patient groups classified according to clinical outcome: reverse transcription polymerase chain reaction (RT-PCR)-confirmed SARS-CoV-2 positive (Groups 1-4);RT-PCR-confirmed SARS-CoV-2 negative following previous SARS-CoV-2 infection (Groups 5 and 6);and RT-PCR-confirmed SARS-CoV-2 negative controls (Group 7). Results: Median levels of CRP, GDF-15, IL-6, and sFlt-1 were significantly higher in patients with SARS-CoV-2 who were admitted to hospital compared with patients who were discharged (all p<0.001), whereas levels of sACE2 were significantly lower (p<0.001). Receiver operating characteristic curve analysis of sACE2 provided cut-offs for the prediction of hospital admission of ≤0.05 ng/mL (positive predictive value: 89.1%) and ≥0.42 ng/mL (negative predictive value: 84.0%). Conclusion: These findings support further investigation of sACE2, either as a single biomarker or as part of a panel, to predict hospitalisation risk and disease severity in patients infected with SARS-CoV-2.

9.
Data Science for COVID-19 Volume 1: Computational Perspectives ; : 1-24, 2021.
Article in English | Scopus | ID: covidwho-1787938

ABSTRACT

Following the World Health Organization proclaims a pandemic due to a disease that originated in China and advances rapidly across the globe, studies to predict the behavior of epidemics have become increasingly popular, mainly related to COVID-19. The critical point of these studies is to discuss the disease’s behavior and the progression of the virus’s natural course. However, the prediction of the actual number of infected people has proved to be a difficult task, due to a wide range of factors, such as mass testing, social isolation, underreporting of cases, among others. Therefore, the objective of this work is to understand the behavior of COVID-19 in the state of Ceará to forecast the total number of infected people and to aid in government decisions to control the outbreak of the virus and minimize social impacts and economics caused by the pandemic. So, to understand the behavior of COVID-19, this work discusses some forecast techniques using machine learning, logistic regression, filters, and epidemiologic models. Also, this work brings a new approach to the problem, bringing together data from Ceará with those from China, generating a hybrid dataset, and providing promising results. Finally, this work still compares the different approaches and techniques presented, opening opportunities for future discussions on the topic. The study obtains predictions with score of 0.99 to short-term predictions and 0.93 to long-term predictions. © 2021 Elsevier Inc. All rights reserved.

10.
60th IEEE Conference on Decision and Control, CDC 2021 ; 2021-December:3544-3550, 2021.
Article in English | Scopus | ID: covidwho-1746107

ABSTRACT

We address the model identification and the computation of optimal vaccination policies for the coronavirus disease 2019 (COVID-19). We consider a stochastic Susceptible-Infected-Removed (SIR) model that captures the effect of multiple vaccine treatments, each requiring a different number of doses and providing different levels of protection against the disease. We show that the inclusion of vaccination data enables the estimation of the state of the model and key model parameters that are otherwise not identifiable. This estimates can, in turn, be used to design strategic approaches to vaccination that aim at minimizing the number of deaths and the economic cost of the disease. We illustrate these results with numerical examples. © 2021 IEEE.

11.
Brazilian Journal of Infectious Diseases ; 26, 2022.
Article in Portuguese | EMBASE | ID: covidwho-1693882

ABSTRACT

A criptococose é uma doença fúngica e oportunista, causada pelo fungo da classe Blastomycetes, da família Cryptococcaceae e apresenta duas espécies patogênicas: C. neoformans e C. gattii. A infecção pode ser adquirida por quaisquer indivíduos saudáveis ou não, mas, as pessoas mais suscetíveis são os portadores de SIDA. A infecção no homem acontece por via respiratória;a levedura atinge os pulmões e, dependendo do estado imunológico do paciente, dissemina-se através por vias hematogênica ou linfática, para o sistema nervoso central, globo ocular e tecido cutâneo. O exame direto com coloração de tinta de nanquim é de fácil execução, rápido e barato permitindo a visualização das estruturas características do Cryptococcus spp, porém, o padrão-ouro para o diagnóstico é a associação do exame histopatológico com a cultura. Anfotericina B, é um medicamento fungicida que em associação a 5-flucitosina, constitui primeira opção de tratamento. Descrição do caso: Paciente feminina, 36 anos, venezuelana, com diagnostico de infecção pelo HIV há aproximadamente 2 anos, porém sem tratamento antirretroviral regular. Foi admitida em agosto de 2021 no Hospital de referência de Roraima por alteração neurológica (afasia, hemiparesia direita e alteração da marcha) com achados sugestivos de leucoencefalopatia multifocal progressiva (LEMP) na ressonância magnética do encéfalo;foi diagnosticada também com COVID-19. Durante a internação, evoluiu com surgimento de lesões elevadas, circunscritas, hipercrômicas em face, pescoço, tronco e membros superiores e lesão ulcerada de bordas elevadas de aproximadamente 5 cm na face medial do tornozelo esquerdo. Realizada biópsia das lesões que demonstraram infiltrado inflamatório linfohistiocitário, com esporos fúngicos de variados tamanhos, com cápsula espessa que se coram pela coloração HE e mais nitidamente pelo Grocott sugestivo de infecção por Cryptococcus neoformans. Análise de líquor realizado em 2 oportunidades teve exames diretos e culturas negativas para estruturas fúngicas;não foi possível realizar teste de aglutinação em Latex para Cryptococcus. Fez uso de Anfotericina B lipossomal e Fluconazol por 2 semanas, evoluindo com boa resposta cutânea, porém sem melhora do quadro neurológico. Comentário: A criptococose cutânea localizada uma condição na qual as lesões estão confinadas à pele, não disseminadas sistemicamente e ao mesmo tempo, não estão associadas a fungemia.

12.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-326831

ABSTRACT

Statement: The enrichment analysis of discriminative cell transcriptional responses to SARS-CoV-2 infection using biclustering produces a broader set of superiorly enriched GO terms and KEGG pathways against alternative state-of-the-art machine learning approaches, unraveling novel knowledge. Motivation and methods: The comprehensive understanding of the impacts of the SARS-CoV-2 virus on infected cells is still incomplete. This work identifies and analyses the main cell regulatory processes affected and induced by SARS-CoV-2, using transcriptomic data from several infectable cell lines available in public databases and in vivo samples. We propose a new class of statistical models to handle three major challenges, namely the scarcity of observations, the high dimensionality of the data, and the complexity of the interactions between genes. Additionally, we analyse the function of these genes and their interactions within cells to compare them to ones affected by IAV (H1N1), RSV and HPIV3 in the target cell lines. Results: Gathered results show that, although clustering and predictive algorithms aid classic functional enrichment analysis, recent pattern-based biclustering algorithms significantly improve the number and quality of the detected biological processes. Additionally, a comparative analysis of these processes is performed to identify potential pathophysiological characteristics of COVID-19. These are further compared to those identified by other authors for the same virus as well as related ones such as SARS-CoV-1. This approach is particularly relevant due to a lack of other works utilizing more complex machine learning tools within this context.

13.
Journal of Open Innovation: Technology, Market, and Complexity ; 8(1), 2022.
Article in English | Scopus | ID: covidwho-1674696

ABSTRACT

Every day, companies are exposed to various risks arising from their environment, and small and medium enterprises (SMEs) are the most affected. This study emphasizes innovation and resilience as the starting points to understand how SMEs are influenced by external factors which are independent of the managers’ will. To date, we have seen several extreme factors that have conditioned businesses and entrepreneurs of these types of companies, such as the financial crisis of 2008. However, last year, in 2020, we saw the beginning of a worldwide pandemic: COVID-19. Thus, this research seeks to understand the extent to which this pandemic influenced the resilience and innovation of SMEs in the tourism area. Thus, eight hypotheses were raised based on four independent variables: access to finance, risk taking, working conditions, and personal network. The study of these variables was developed from an online questionnaire and in-depth interviews. After analyzing the results, it is possible to infer that the COVID-19 pandemic resulted in consequences never observed in previous crises, to such an extent that the study showed that: (1) a company’s network positively influences its resilience;(2) risk taking influences innovation and resilience of these SMEs. © 2022 by the authors. Licensee MDPI, Basel, Switzerland.

14.
9th International Conference on Technological Ecosystems for Enhancing Multiculturality, TEEM 2021 ; : 794-799, 2021.
Article in English | Scopus | ID: covidwho-1613102

ABSTRACT

The use of technology in Education helped teaching plans reach students almost anywhere during the COVID Pandemic and some positive effects regarding the planet sustainability were also reported during this phase. A questionnaire was conducted in order to assess if students felt any resource productive in their learning and would like to keep it, contributing to lesser their ecological footprint. The more advantages to sustainability they recognize, the more educational resources they would like to keep using and the more favorable they are for a hybrid educational regime. © 2021 ACM.

15.
Journal of Biomolecular Structure & Dynamics ; : 14, 2022.
Article in English | Web of Science | ID: covidwho-1612284

ABSTRACT

COVID-19, a disease caused by the SARS-CoV-2 virus, is responsible for a pandemic since March 2020 and it has no cure. Therefore, herein, different theoretical methods were used to obtain potential candidates from herbal compounds to inhibit the SARS-CoV-2 main protease (M-pro). Initially, the 16 best-scored compounds were selected from a library containing 4066 ligands using virtual screening by molecular docking. Among them, six molecules (physalin B 5,6-epoxide (PHY), methyl amentoflavone (MAM), withaphysalin C (WPC), daphnoline or trilobamine (TRI), cepharanoline (CEP) and tetrandrine (TET)) were selected based on Lipinski's rule and ADMET analysis as criteria. These compounds complexed with the M-pro were submitted to triplicate 100 ns molecular dynamics simulations. RMSD, RMSF, and radius of gyration results show that the overall protein structure is preserved along the simulation time. The average Delta G(binding) values, calculated by the MM/PBSA method, were -41.7, -55.8, -45.2, -38.7, -49.3, and -57.9 kcal/mol for the PHY-M-pro, MAM-M-pro, WPC-M-pro, CEP-M-pro, TRI-M-pro, and TET-M-pro complexes, respectively. Pairwise decomposition analyses revealed that the binding pocket is formed by His41-Val42, Met165-Glu166-Leu167, Asp187, and Gln189. The PLS regression model generated by QSPR analysis indicated that non-polar and polar groups with the presence of hydrogen bond acceptors play an important role in the herbal compounds-M-pro interactions. Overall, we found six potential candidates to inhibit the SARS-CoV-2 M-pro and highlighted key residues from the binding pocket that can be used for future drug design. Communicated by Ramaswamy H. Sarma

16.
European Journal of Public Health ; 31:391-391, 2021.
Article in English | Web of Science | ID: covidwho-1610007
17.
Health ; 13(8):830-838, 2021.
Article in English | CAB s | ID: covidwho-1547588

ABSTRACT

In the face of new diseases, medicine needs to reinvent itself in order to contain and control epidemics, such as the one we have recently faced, COVID-19, a disease with a wide spectrum of clinical severity. A new moment has been established, since the application of well-known, effective and safe medications for other diseases, has shown high success rates in the treatment of COVID-19. Thereunto, studies with early intervention are needed, which can change the unfavorable outcome of patients. In this article, we report the successful experience using an oral strategy during the collapse of Belem (Para, Brazil) Health System. Two hundred and ten patients were diagnosed with respiratory failure due to COVID-19, with no option of hospital treatment due to lack of beds and resources. These patients were then started on therapeutic regimen consisting of 40 mg prednisolone, 40 mg enoxaparin and macrolides (500 mg clarithromycin, 500 mg axetylcefuroxime) associated and followed in outpatient facilities. Two hundred and eight patients had an excellent therapeutic response and there were only two fatalities. These results push research boundaries, valuing outpatient treatment with early use of prednisolone in the initial pulmonary phase, preventing severe COVID-19 pneumonitis. Adoption of the proposed treatment intends to reduce the need for hospitalization, as well as lethality, with social robust benefits and incalculable economic savings since involves the use of accessible, safe and not expensive medications.

18.
European Journal of Public Health ; 31, 2021.
Article in English | ProQuest Central | ID: covidwho-1515001

ABSTRACT

Health-care workers (HCWs) on the frontlines have a high risk of acquiring and dying from covid-19. Nursing professionals (NP) represent over half of HCWs in Brazil, a country with high morbidity and mortality from covid-19, above all in 2021. The absenteeism and death of nursing professionals due to covid-19 have a major impact on the workforce. As part of the research by Fiocruz on working conditions among HCWs, including those considered “invisible,” we have conducted this study of death among graduated nurses. Although they represent 4 out of 5 members of nursing teams in Brazil, the technicians and assistant nurses remains largely unseen and are covered by the “invisible” HCW study. We analyzed data from Federal Council of Nurses, publicized at the website Observatorio da Enfermagem. The sociodemographic profile, professional category and timeline of nursing professional deaths were considered. The time period of the study was from March 2020 to March 2021. A total of 670 professionals of the nursing team died, 200 of these were nurses. Among nurses: 59.5% were female and 81.5% were up to 60 years old. Our study registers a concentration of deaths in the North region. Despite having fewer registered professionals, it had the highest number of deaths (29.5%), and the Southeast had the second highest percentage (26.5%). A slow decline was observed until December, when Brazil experienced a “second wave” of Covid-19. Vaccination of Nurses began in late January 2021;therefore, there was not enough time to assess the impact on morbidity and mortality. The results of a study of almost 50 professional categories are under analysis and will be published shortly. Key messages This study is about death by COVID-19 among nurses in Brazil. This study is part of a large one on professional categories, essentials to supporting health care system, conducted by FIOCRUZ.

19.
Journal of the Neurological Sciences ; 429, 2021.
Article in English | EMBASE | ID: covidwho-1466691

ABSTRACT

Background and aims: Opicapone (OPC) proved to be effective in the treatment of end-of-dose motor fluctuations in Parkinson's disease (PD) patients. Non-motor symptoms have a substantial impact on health-related quality of life and are reported in approximately 90% of idiopathic PD patients. End-of-dose motor fluctuations and associated sleep disorders are commonly observed in PD patients who receive treatment with levodopa (L-dopa)/DOPA decarboxylase inhibitors (DDCI). This study aims to evaluate the effects of OPC treatment on sleep disorders in PD patients with ‘wearing-off’. Methods: Approximately 30 patients (aged ≥30 years) with idiopathic PD, treated with 3–8 daily doses of L-dopa/DDCI, with ‘wearing-off’ and sleep disorders will receive OPC 50 mg once daily during a 6-week evaluation period. L-dopa/DDCI daily dose, but not number of intakes, may be adjusted according to the patients' response in the first 2 weeks, and is kept unchanged afterwards (Fig. 1). As a pilot study, no formal sample size calculation was performed. [Formula presented] Results: The primary endpoint is change from baseline in total score of Parkinson's Disease Sleep Scale-2. Secondary endpoints include tolerability, functional motor and non-motor assessments (Movement Disorder Society-Non-Motor Symptoms Scale, Parkinson's Disease Questionnaire-8, Parkinson's Fatigue Scale, ON/OFF home diary), and Clinical and Patient Global Impression of Change scales. Study sites are in Germany and Portugal. First-patient-in is expected for early 2021 and last-patient-out for late 2021. Timelines might be impacted by the COVID-19 situation. Conclusions: This pilot study will provide preliminary data on the potential effect of OPC 50 mg once daily as adjunctive therapy to L-dopa/DDCI on PD-associated sleep disorders.

20.
Journal of the Neurological Sciences ; 429, 2021.
Article in English | EMBASE | ID: covidwho-1466690

ABSTRACT

Background and aims: Opicapone (OPC) proved to be effective in the treatment of end-of-dose motor fluctuations in Parkinson's disease (PD) patients. About 80–100% of PD patients show some degree of wearing-off within 10 years of levodopa (L-dopa) therapy. Approaches to optimize the L-dopa regimen include increasing the dose or ‘fractionating’ the total daily dose. This study aims to explore the potential of adjunctive OPC versus an additional dose of L-dopa/dopa decarboxylase inhibitor (DDCi) to optimize the L-dopa/DDCi regimen as first-line approach to treat wearing-off. Methods: Approximately 100 patients (aged ≥30 years) with idiopathic PD, treated with 3–4 daily oral L-dopa doses up to 600 mg, and signs of wearing-off (<2 years) will be equally randomized to receive OPC 50 mg once daily or an additional dose of 100 mg/25 mg L-dopa/DDCI during a 4-week open-label evaluation period (Fig. 1). [Formula presented] Results: Primary endpoint is the change from baseline in OFF-time. Secondary endpoints include tolerability, functional motor and non-motor assessments (Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale, MDS-Non-Motor Symptoms, Parkinson's Disease Questionnaire-8), and global impression of change scales (Clinical Global Impression of Change, Patient Global Impression of Change). As this is a descriptive/exploratory study, no formal sample size calculation was performed. Study sites are in Germany, Italy, Portugal, Spain, and the UK. First-patient-in is expected for 2021 and last-patient-out for late 2022. Timelines might be impacted by the COVID-19 situation. Conclusions: This study will evaluate the potential of adjunctive OPC versus an additional dose of L-dopa/DDCi as first-line approach to treat wearing-off in PD patients.

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